Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06104241
Other study ID # BR-BGT-007
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date October 22, 2023
Est. completion date October 20, 2027

Study information

Verified date October 2023
Source The Affiliated Hospital of Xuzhou Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is an exploratory clinical study evaluating the safety and initial efficacy of BGT007 injection in the treatment of recurrent/metastatic/refractory digestive system tumors


Description:

The researchers designed a single arm, open, exploratory study to improve the "3+3" dose escalation. The maximum dose or the best effective dose shall be determined according to the subject and dose increasing test to verify the safe and effective number of cells per unit weight. The improved "3+3" dose increasing design was adopted, and BGT007 cells were set with 5 dose groups that were gradually increased for treatment evaluation. The dose groups were 5.0 × 10^7cells,1.0 × 10^8cells,3.0 × 10^8cells,1.0 × 10^9cells,3.0 × 10^9cells. Cell reinfusion will be carried out on day 0 (d0), and each subject will be observed for at least 4 weeks after receiving cell reinfusion (DLT observation period).


Recruitment information / eligibility

Status Recruiting
Enrollment 14
Est. completion date October 20, 2027
Est. primary completion date October 20, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. Voluntarily sign a written informed consent. 2. Age =18 years old, =70 years old, male and female. 3. Expected survival = 3 months. 4. The Eastern Cancer Collaboration (ECOG) physical fitness score was 0-1. 5. Biopsy specimen or pathological wax section test (within 3 years before the signing of informed consent): Target protein test is positive. 6. At least one measurable lesion according to RECIST v1.1 solid tumor evaluation criteria. 7. Patients with recurrent/metastatic refractory digestive tract tumors (esophageal, gastric, pancreatic, or colorectal cancer) who have previously received second-line or above standard treatment failure or intolerance. 8. It is possible to establish a vein access for simple or intravenous blood collection, and there are no other contraindications for blood cell separation. 9. having adequate organ and bone marrow function, as defined below: Blood routine examination Neutrophil count (NEU #) =1.0×10^9/L Platelet count (PLT) =80×10^9/L Hemoglobin concentration =90g/L Liver function: subjects without liver metastases Aspartate aminotransferase (AST) =2.5× Upper Limit of Normal (ULN) Alanine aminotransferase (ALT) =2.5× Upper Limit of Normal (ULN) Total bilirubin (TBIL) =1.5×ULN Liver function: Subjects with liver metastases Aspartate aminotransferase (AST) =5× Upper limit of normal (ULN) Alanine aminotransferase (ALT) =5× Upper limit of normal (ULN) Liver function: Subjects with liver metastases or Gilbert syndrome Total bilirubin (TBIL) =2×ULN renal function Creatinine clearance (CCR) =50 mL/min Coagulation function International Standardized ratio (INR) =1.5×ULN Activated partial thromboplastin time (APTT) =1.5×ULN 10. Toxic side effects left over from previous anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, etc.) = grade 1 (CTCAE 5.0). 11. During the study period and for 6 months after the end of dosing, fertile subjects (both male and female) must use effective medical contraception. For female subjects of reproductive age, a pregnancy test should be performed within 72 hours before the first dose and the result are negative. Exclusion Criteria: 1. Active central nervous system metastases (except those stable after treatment). 2. HIV positive, HBsAg positive, HBV DNA copy number positive (quantitative detection =1000cps/ml), HCV antibody positive and HCV RNA positive. 3. Patients with mental or mental illness who cannot cooperate with treatment and efficacy evaluation. 4. Subjects with severe autoimmune diseases and long-term use of immunosuppressants. 5. Active or uncontrolled infections requiring systemic treatment during the 14 days prior to enrollment. 6. Any unstable systemic disease (including but not limited to): Active infections (except local infections); unstable angina pectoris; cerebral ischemia or cerebrovascular accident (within 6 months prior to screening); myocardial infarction (within 6 months before screening); Congestive heart failure (New York Heart Association [NYHA] classification =III); Severe arrhythmias requiring medical treatment; have a heart condition that requires treatment or uncontrolled hypertension after treatment (blood pressure > 160mmHg/100 mmHg). 7. dysfunction of important organs such as lung, brain and kidney. 8. The subject has undergone major surgery or severe trauma within 4 weeks prior to receiving cell therapy or is expected to undergo major surgery during the study period. 9. Received any systemic chemotherapy, immunotherapy, or small molecule targeted therapy within 1-2 weeks prior to an apheresis or within 5 half-lives, whichever is shorter. 10. The subject currently has or has had other malignant tumors that cannot be cured within 3 years, except cervical carcinoma in situ or basal cell carcinoma of the skin, and other malignant tumors with disease-free survival of more than 5 years. 11. Received chimeric antigen receptor modified T cells (including CAR-T, TCR-T) within six months. 12. Graft-versus-host disease (GVHD). 13. Participants who were receiving systemic steroid therapy prior to screening and who were determined by the investigator to require long-term use of systemic steroid therapy during treatment (except for inhalation or topical use); And subjects treated with systemic steroids within 72 h prior to cell transfusion (except for inhalation or topical use). 14. Severe allergies or history of allergies. 15. Subjects requiring anticoagulation therapy. 16. Pregnant or breastfeeding women, or have a pregnancy plan within six months (for both men and women) 17. Researchers believe that there are other reasons for not being included in the treatment.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
BGT007 Injection
BGT007 injection (d0) were infused intravenously once, and the dose group was 5.0× 10^7 cells,1.0 ×10^8 cells, 3.0× 10^8 cells,1.0 × 10^9 cells,3.0 ×10^9 cells.

Locations

Country Name City State
China he Affiliated Hospital of Xuzhou Medical University Xuzhou JangSu

Sponsors (2)

Lead Sponsor Collaborator
The Affiliated Hospital of Xuzhou Medical University Guangzhou Bioresette Biomedical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose-limiting toxicity (DLT) Adverse events related to cell therapy were observed on 28 days after BGT007 injection, as specified in protocol. From day 0 to day 28
Secondary C max The amplification of BGT007 injection in peripheral blood peaked after administration. 12 months
Secondary T max Number of days of peak BGT007 injection expansion after administration. 12 months
Secondary ORR Reportion of patients who achieved pre-defined tumor volume reduction and maintained the minimum time limit. Imaging examination was performed after administration, and RECIST1.1 evaluation criteria was used for evaluation. 12 months
Secondary PFS The time from the onset of leukocyte apheresis to the appearance of tumor progression or death. 12 months
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Not yet recruiting NCT05044312 - Sleep Disturbances in Surgical Patients With GI Cancers: A Quantitative and Qualitative Analysis N/A
Active, not recruiting NCT05053191 - Advancing Nursing Practices in Hospital Oncology Care N/A
Completed NCT03611309 - Perioperative Palliative Care Surrounding Cancer Surgery for Patients & Their Family Members N/A
Recruiting NCT03602677 - Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage N/A
Recruiting NCT03190941 - Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients Phase 1/Phase 2
Not yet recruiting NCT06398314 - Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors N/A
Withdrawn NCT04030624 - Remote Electronic Patient Monitoring in Gastrointestinal Cancer N/A
Completed NCT02222259 - A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients N/A
Completed NCT02140593 - The Laparotomy Study Phase 4
Active, not recruiting NCT00716209 - Infrastructure for Developing Gastrointestinal Cancer Prognostic and Predictive Markers N/A
Recruiting NCT01484444 - Biomarker Analysis of Gastrointestinal Cancer N/A
Completed NCT02130427 - A Volume, Motion, and Anatomically Adaptive Approach to Photon and Proton Beam Radiotherapy N/A
Active, not recruiting NCT00710632 - Screening to Predict Weight Loss in Patients With Cancer N/A
Completed NCT00094965 - Oxaliplatin With FOLFOX4 in Patients With Normal and Abnormal Renal Function Phase 2
Terminated NCT04077372 - Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers N/A
Recruiting NCT04899908 - Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases Phase 2
Recruiting NCT05429866 - Immunological Variables Associated to ICI Toxicity in Cancer Patients Phase 2
Recruiting NCT05226221 - Gastrointestinal Emergency Surgery: Evaluation of Morbidity and Mortality
Recruiting NCT03286348 - Analysis of Nutrition During Chemoradiotherapy in Patients With Gastrointestinal Cancer N/A